POLYTECH Health & Aesthetics GmbH
DE-MF-000018836 · Germany · Dieburg
POLYTECH Health & Aesthetics GmbH is registered in the European database on medical devices as a manufacturer, with 4 795 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 3 558 |
|---|---|
| Class IIa | 913 |
| Class IIb | 324 |
Most frequent device types declared: Mammary implant, Sizer, Breast expander, Body contouring implant, Tissue expander.
Among these devices, 4 795 are declared sterile, 3 882 implantable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 4 795 |
| Country of registration | Germany |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.